Manager, Quality - Escalations and Field Actions

Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Description

Position Overview

The Manager of Quality - Escalations and Field Actions will have responsibilities in planning, implementing, execution, standardizing, and managing product related Escalations to Risk Management Board, Quality Review Board, and Field Corrective Actions (FCA).

This positions requires a minimum of 3 days a week in the Santa Clara office.

Essential Job Function

The Manager of Quality - Escalations and Field Actions will collaborate with business partners to ensure compliance to all regulatory requirements, standard requirements, and internal procedures. Specific areas of focus will be:

• Responsible for establishing and maintaining policies and procedures to ensure compliance with local, state and federal environmental regulations and standards including compliance with all Food & Drug Administration (FDA) and European Union Medical Device Directives (MDD)/European Union Medical Device Regulation (MDR) as well as all other applicable global regulatory requirements.
• Responsible for compliance with applicable Enterprise and Franchise Policies and procedures.
• Schedule, coordinate and prepare for Issue Escalation RMB and Quality Review Board Meetings by gathering all required information from all sites/required groups, performing dry runs, managing the process, preparing minutes, following up on action items and maintaining records.
• Responsible for establishing and maintaining policies and procedures to ensure compliance with local, state, and federal environmental regulations and standards.
• Manage, maintain, and improve and standardize RMB, QRB, FCA processes to ensure compliance with FDA regulations and ISO Standards.
• Schedule, coordinate, follow-up for RMB and QRB meetings and maintain related files.
• Manage field corrective actions, any associated regulatory actions and follow-ups including support to field action coordinators globally; assist in product problem resolution as part of follow-up from QRB and CAPA.
• Track all activities associated with the escalation process to assure compliance with all applicable policies and procedures, including:
• Responsible for the coordination of field action activities including preparing documentation for recordable and reportable field actions.
• Track customer communications for effectiveness verification.
• Complete interim status reports to the FDA at the required intervals.
• Prepare and maintain electronic and hard copy recall files.
• Prepare or assist leadership with monthly reports.
• Lead or participate in process improvement projects.
• Maintain up-to-date knowledge of FDA & EU regulations and other applicable worldwide standards and requirements specifically as related to medical device industry and quality system regulations.
• Implement/modify quality systems to address changing Regulations or industry standard, providing regulatory interpretation and guidance where required.
• Advise staff to help meet established schedules or resolve technical operations problems
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Manage and oversee the initiation of product shipment holds and ensuring appropriate documentation is provided/completed to release, transfer and/or scrap product on shipment hold.
• Other duties assigned as assigned.
  
  

Requirements

• BS degree in a related discipline.
• 10 years’ experience in medical device quality systems and compliance role including a minimum of 2 years of managerial experience.
• Ability to interpret and apply regulatory requirements and industry best practices.
• Management skills with demonstrated ability to effectively train, mentor, and influence a diverse array of employees at all levels of the organization.
• Thorough knowledge of Quality, Regulatory compliance, and operations systems and processes, including GMP and QSR requirements for medical devices.
• Advanced knowledge of IS013485:2016, FDA's QSRs, EU's MDD/MDR, Canadian Regulations, and MDSAP.
• Ability to use broad knowledge of regulatory, technical, and business requirements to effectively lead, implement, and manage various quality systems and compliance for Shockwave and Johnson & Johnson.
• Excellent interpersonal skills, negotiation and influencing skills. Strong oral and written communications skills with ability to speak to broad, non-technical audiences that are both internal and external personnel.
• Skilled at preparing executive briefings and broad communications.
• Ability to make solid decisions that will effectively support the business and company policies.
• Ability to work in fast paced environment and rapidly shifting priorities with business and financial acumen. Highest ethical standards and integrity.
• Project Management experience and excellent organizational skills is preferred.
• Remains current with regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings.
• Ability to work in a fast-paced environment while managing multiple priorities.
• Operate as a team and/or independently while demonstrating flexibility to changing requirements.
  
  

Market Range: $136,000 - $170,000

Exact compensation may vary based on skills, experience, and location.

Benefits

Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks:

Core Benefits: Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balance

Perks: ESPP, Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards

EEO Employer